WEDNESDAY, NOVEMBER 7
1-1:50pmRaw Material Documentation and GMP Compliance
With the implementation of the Food Safety and Modernization Act, the dietary supplement industry must place greater emphasis on increasing traceability of the supply chain to ensure the manufacture of quality products and the prevention of economically motivated adulteration. Failure in creating and keeping appropriate documentation is one of the common GMP deficiencies flagged by FDA 483s and warning letters. Key to knowing your product, from “seed to shelf,” is the assessment of raw materials intended to be manufactured into finished products. This process involves retrieval, review and approval of important documentation related to the raw material, including specification sheets, certificates of analysis, identity tests, GMO labeling statements and manufacturing information. The efficiency of the documentation process contributes to resource savings as well as confidence in the safety and quality of finished products.